UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039793 |
|---|---|
| Receipt number | R000045361 |
| Scientific Title | Early rehabilitation provided by specialized physical therapist in an emergency center reduces pulmonary complications in patients with sepsis: A retrospective cohort study |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2020/03/12 18:08:44 |
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Basic information
Public title
arly rehabilitation provided by specialized physical therapist in an emergency center reduces pulmonary complications in patients with sepsis: A retrospective cohort study
Acronym
Early rehabilitation and pulmonary complications
Scientific Title
Early rehabilitation provided by specialized physical therapist in an emergency center reduces pulmonary complications in patients with sepsis: A retrospective cohort study
Scientific Title:Acronym
Early rehabilitation and pulmonary complications
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this retrospective cohort study was to evaluate if early rehabilitation provided by specialized physical therapist in the emergency center could reduce respiratory complication in sepsis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome measure is the association between early mobilization by specialized physical therapy and the onset of a pulmonary complication.
The evaluation period is during the hospital stay.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects of this study were sepsis patients who entered the AECCC of Shinshu University Hospital between April 2014 and March 2019.
Participants >18 years who received intensive treatment and were diagnosed with sepsis or septic shock and who met the inclusion criteria were enrolled.
Key exclusion criteria
Patients with head injuries, burns, spinal injuries, lower limbs with multiple fractures, and those with septic shock who were unresponsive to maximal treatment, moribund or had an expected mortality within 24h were excluded.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakai |
Organization
Shinshu University Hospital
Division name
Rehabilitation
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
TEL
0263-37-2836
yasunari_sakai1028@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakai |
Organization
Shinshu University Hospital
Division name
Rehabilitation
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
TEL
0263-37-2836
Homepage URL
yasunari_sakai1028@yahoo.co.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Non.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
Tel
0263-37-2572
mdrinri@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
128
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participant age, sex, body mass index, sequential organ failure assessment score, systemic inflammatory response syndrome score, disseminated intravascular coagulation score, laboratory data, primary source of infection, use of therapeutic medication, use of mechanical ventilation, length of hospital stay, the number of days until rehabilitation was achieved, the baseline Barthel index, and the incidence of pulmonary complications are recorded.
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045361
